Brief Summary
This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen
Brief Title
Acetaminophen (APAP) +/- Oxycodone
Categories
Completion Date
Completion Date Type
Actual
Conditions
Musculoskeletal Pain
Eligibility Criteria
Inclusion Criteria:
* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity
Exclusion Criteria:
* Use of an non-steroidal anti-inflammatory drug within the previous six hours
* Use of acetaminophen within the previous six hours
* Use of an opioid within the previous ten days
* Chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain
* Gout
* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity
Exclusion Criteria:
* Use of an non-steroidal anti-inflammatory drug within the previous six hours
* Use of acetaminophen within the previous six hours
* Use of an opioid within the previous ten days
* Chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain
* Gout
Inclusion Criteria
Inclusion Criteria:
* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity
* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04122443
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10592
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen
Primary Outcomes
Outcome Description
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
Outcome Measure
Change in Pain Assessment
Outcome Time Frame
2 hours following treatment
Secondary Outcomes
Outcome Description
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category.
Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category.
Outcome Time Frame
Up to 48 hours following medication administration
Outcome Measure
Sustained Pain Relief
Outcome Description
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category.
Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category.
Outcome Time Frame
2 hours following treatment
Outcome Measure
Adequacy of Analgesia
Outcome Description
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure"
Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure"
Outcome Time Frame
2 hours following treatment
Outcome Measure
Satisfaction With Medication
Outcome Description
Stage 1 (Open label): No Outcome Measures assessed
Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.
Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.
Outcome Time Frame
2 hours following treatment
Outcome Measure
Medication-related Adverse Events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415